Office of the Institutional Review Board
IRB Meeting

Guidance

Note: Posted Guidance documents on this website do not represent an all inclusive list. Please call the Office of the IRB at 210-567-8250 with any questions concerning current guidance.

Instructions:

Always return to this webpage to ensure you are using the most current Guidance.

Advertising - Guidelines for Advertising for Research Subjects

Related Policy: Identification and Recruitment of Participants
pdf for PC

Assurance Letter

A letter containing the UTHSCSA FWA number, numbers of the IRBs listed under this FWA and a list of affiliated institutions covered by the IRB under general IRB Authorization Agreements.

pdf for PC
CITI Instructions (Sign-up and affiliate)   pdf for PC
CITI Instructions (Navigate to courses)   pdf for PC

CITI Learner Groups - Instructions on changing CITI Learner Group

  pdf for PC
Community Participatory Research Guidance  
pdf for PC

Consenting Process - Guidance on Observation of the Consenting Process

Related Policy: Informed Consent
pdf for PC
DoD Research See the Policy: DoD Research Policy and Procedure

Existing Specimens -Guidelines for IRB Applications Involving the Use of Existing Specimens

 
pdf for PC

Gender Differences - FDA Guidance on Study of Gender Differences in the Clinical Evaluation of Drugs

 
pdf for PC
LAR - Guidance related to legally effective informed consent under HHS, FDA, VA regulations and Texas state law “Legally Authorized Representatives Under Federal and Texas Law”
pdf for PC

Information Sheet - Checklist for Elements of an Information Sheet

Related Policy: Informed Consent
pdf for PC

Informed Consent - Checklist for Elements of Informed Consent

Related Policy: Informed Consent pdf for PC

IRB Guidance on Data and Safety Monitoring Plan

 
pdf for PC
Planned Emergency - Guidance on Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent   pdf for PC

Pregnancy Exposure Registry -
FDA Guidance for Industry: Establishing Pregnancy Exposure Registries

  FDA Guidance
Recruitment - Guidance on UT Medicine Patient Recruitment Related Policy: Identification and Recruitment of Participants
pdf for PC

Waivers and Alterations Guidance

Related Policy: Informed Consent
pdf for PC